Safety of interferon beta-1β in children and adolescents

The first multicentre review of the safety and tolerability of IFNb-1b in children and adolescents has shown that the therapy is well-tolerated, but data on long-term effects on organs are lacking.The review authors point out that at least 5% of all patients with MS experience the clinical onset of disease prior to 18 years of age, but data on the safety and efficacy of immunomodulatory therapies in patients younger than 18 years are lacking, as pivotal studies were limited to older patients. They retrospectively reviewed data on the safety and tolerability of IFNb-1b in a cohort of 43 children treated for a mean of 29.2 months. The mean age for commencement of interferon treatment was 13 years, and eight children were 10 years of age or less when they commenced therapy. No serious adverse events were reported, and there were no unexpected adverse events in the cohort. The milder adverse events were consistent with those expected, based on adult population studies, and included flu-like syndrome and reaction at the injection site. However, clinically-relevant elevations in liver transaminases occurred in four of the eight children 10 years or younger and in three of 30 children over 10 years in whom liver function tests were performed, and the authors say monitoring of liver function is indicated in all children receiving IFNb-1b.The effect of interferon treatment on relapse rate was evaluated in 38 of the patients, and showed a mean percent reduction in annualised relapse rate of 50% (median 65%). However, the authors say this finding should be treated with caution, due to the natural history of MS and the lack of a control group in their review. The authors conclude that their review supports a reasonable safety profile for the use of IFNb-1b in children with active MS, but that the potential impact of the therapy on maturing organ systems must be considered and long-term follow-up data are required.Reference...